DEVICE: IH-Card AHG Anti-IgG (07611969952168)
Device Identifier (DI) Information
IH-Card AHG Anti-IgG
813421100
In Commercial Distribution
813421100
Bio-Rad Medical Diagnostics GmbH
813421100
In Commercial Distribution
813421100
Bio-Rad Medical Diagnostics GmbH
Anti-Human Globulin Anti-IgG; Gel card for use with the IH-system; Card for direct and indirect antiglobulin test; 48 cards of 6 microtubes
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
Yes | |
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No | |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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45811 | Polyspecific antihuman globulin IVD, antibody |
One or multiple immunoglobulins capable of binding to all classes of human immunoglobulin antibodies fixed to red blood cells and intended to be used in immunohaematological testing of a clinical specimen to detect red blood cell sensitization by human immunoglobulin, using an agglutination or solid-phase red blood cell adherence method.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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No Product Codes |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Upright position |
Storage Environment Temperature: between 18 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3734a44c-5b2b-490a-b0c2-6617a74f0805
May 24, 2021
3
January 20, 2017
May 24, 2021
3
January 20, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-224-6723
techsupport.bmd@bio-rad.com
techsupport.bmd@bio-rad.com